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510(k) Data Aggregation

    K Number
    K970774
    Device Name
    TEMPOCEM NE (MULTIPLE)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1997-06-03

    (91 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K984340
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TempoCem N/E is a dental luting agent for the temporary cementation of crowns and bridges.

    Device Description

    Not Found

    AI/ML Overview

    The document provided is a 510(k) premarket notification letter from the FDA for a dental luting agent called TempoCem N/E. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not a medical imaging or AI-driven device.

    Therefore, I cannot fulfill your request using the provided text. The document is about a dental cement and its regulatory approval process, not about a device that undergoes performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

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